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Model Number 26665 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/20/2022 |
Event Type
malfunction
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Event Description
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It was reported that a foreign material was found near the stent.A 8x29, 5f, 135cm carotid wallstent was selected for use to treat the lesion.After the device was flushed and removed the stylus, a piece of stylus or some sort of foreign material was found near the stent and another flushing was performed.The procedure was completed with another carotid wallstent.No patient complications were reported.
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Event Description
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It was reported that a foreign material was found near the stent.A 8x29, 5f, 135cm carotid wallstent was selected for use to treat the lesion.After the device was flushed and removed the stylus, a piece of stylus or some sort of foreign material was found near the stent and another flushing was performed.The procedure was completed with another carotid wallstent.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr.: carotid wallstent mr 8x29, 5f, 135cm was received for analysis.During the product analysis a bsc0.014" filterwire was advanced through this device without issue.No obstruction or foreign material (fm) was identified within the guidewire lumen.A visual and tactile examination identified a shaft kink 130mm proximal of the guidewire port.This type of damage is consistent with excessive force being applied to the device.The device was returned with the stent mounted fully constrained in the correct location on the device.The investigator successfully deployed the stent without issue.No damage or issues were noted with the deployed stent.The black stent holder of the device was clearly visible both before and after deployment of the stent.No fm was identified on or within the device before or post stent deployment.
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Search Alerts/Recalls
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